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Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01307085
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection.

Condition or disease Intervention/treatment
Lung Neoplasms Procedure: remote ischemic preconditioning

Detailed Description:
Remote ischemic preconditioning is an intervention in which brief ischemia of one tissue or organ protects remote organs from a sustained episode of ischemia. It is known that one-lung ventilation in patients undergoing pulmonary resection, which may cause acute lung injury. The investigators did a single-blinded randomised controlled study to establish whether remote ischemic preconditioning reduces lung injury in these patients.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Resection:a Randomised Controlled Trial
Study Start Date : February 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: preconditioning
Adult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia.
Procedure: remote ischemic preconditioning
Remote ischaemic preconditioning consisted of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Other Name: RIP
No Intervention: conventional
Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia.


Outcome Measures

Primary Outcome Measures :
  1. Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy [ Time Frame: June,2013 ]
    PaO2/FiO2 in the limb RIPC group was significantly higher than that in the control group at 30 and 60 min after OLV, 30 min and 6 h after operation (all P<0.05)


Secondary Outcome Measures :
  1. Cs and Cd [ Time Frame: June,2013 ]
    Cs and Cd in limb RIPC group were significantly higher than those in the control group at 30 and 60 min after OLV (all P<0.05)

  2. IL-6 and TNF-α [ Time Frame: June,2013 ]
    The IL-6 levels in the limb RIPC group were lower than those in the control group at 30 min, 6, 12, 24 and 48 h after operation (all P<0.05), and there was a significant difference in TNF-α level between the groups (P<0.01).


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of pulmonary carcinoma
  • Must be received pulmonary lobectomy

Exclusion Criteria:

  • Cardiac disease categorized as NYHA classes II-IV
  • Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) <60 mmHg or FEV1<50% predicted),
  • Pre-existing coagulopathy or thrombocytopenia
  • Prior receipt of chemotherapy or radiation therapy or immunotherapy
  • Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature>38℃)
  • Peripheral vascular disease affecting the upper limbs
  • Administration of vitamins, nonsteroidal anti-inflammatory agent or corticosteroid within 3 months.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307085


Locations
China, Guangdong
Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
GuangZhou, Guangdong, China, 510080
Sponsors and Collaborators
Cai Li
Investigators
Principal Investigator: Xuan Ke Liu, Ph.d Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
More Information

Responsible Party: Cai Li, Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01307085     History of Changes
Other Study ID Numbers: RIP1126
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

Keywords provided by Cai Li, First Affiliated Hospital, Sun Yat-Sen University:
remote ischemic preconditioning
lung injury
pulmonary resection

Additional relevant MeSH terms:
Lung Injury
Lung Neoplasms
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms